...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Clinical therapeutics >Immunologic effects and tolerability profile of in-season initiation of a standardized-quality grass allergy immunotherapy tablet: a phase III, multicenter, randomized, double-blind, placebo-controlled trial in adults with grass pollen-induced rhinoconjunctivitis.
【24h】

Immunologic effects and tolerability profile of in-season initiation of a standardized-quality grass allergy immunotherapy tablet: a phase III, multicenter, randomized, double-blind, placebo-controlled trial in adults with grass pollen-induced rhinoconjunctivitis.

机译：标准化质量草过敏免疫治疗片按季节开始的免疫学影响和耐受性概况：一项针对草花粉诱发的鼻结膜炎的成年人进行的III期，多中心，随机，双盲，安慰剂对照试验。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

BACKGROUND: The summary of product characteristics of the grass allergy immunotherapy tablet (AIT) (Phleum pratense grass pollen allergen extract) states that clinical effect may be observed in the first pollen season of treatment, if treatment is initiated >/=2 months (8 weeks) before the start of the grass pollen season. However, because patients with grass allergy may first present to physicians during the season, immediate treatment initiation (ie, in-season initiation) may increase treatment compliance and reduce the risk for disease progression compared with asking patients to return before the next pollen season to initiate treatment. This "in-season approach" may offer more patients the potentially beneficial treatment option of specific immunotherapy. However, to date, the immunomodulatory effects and tolerability of in-season treatment initiation is unknown. OBJECTIVE: The aim of this study was to assess the immunologic effects and tolerability of in-season initiation of treatment with the grass AIT. METHODS: This multicenter, randomized, double-blind, placebo-controlled trial was carried out in Germany and Austria. Adults with grass pollen allergy (positive skin-prick test and specific grass-pollen immunoglobulin [Ig] E) and grass pollen-induced moderate to severe persistent rhinoconjunctivitis were enrolled. Patients were randomly assigned to receive once-daily grass AIT or placebo, starting during the 2008 grass pollen season and continuing for 8 to 10 weeks. The primary end point was change from baseline in IgE-blocking factor (serum components competing with IgE for allergen binding). Secondary end points included changes from baseline in specific IgE and IgG(4) and measures of tolerability (assessed mainly by adverse events [AEs]). Blood samples for immunologic assessment were obtained by the investigators at baseline and after treatment. All AEs observed by the investigator and/or reported by the patient were recorded throughout the trial and follow-up. RESULTS: A total of 276 patients were enrolled and formed the full analysis set (mean age, 35 years; 55% men, 45% women; 99% white; mean weight, 76 kg; history of asthma, 41%; mean duration of grass allergy, 15.1 years). No major differences in medical history were found between the grass AIT group (n = 219) and the placebo group (n = 57). The change from baseline in mean concentration of IgE-blocking factor was significantly greater with grass AIT compared with placebo (+0.14 vs +0.05; P < 0.0001). The changes from baseline in specific IgE and specific IgG(4) concentrations were significantly greater with AIT compared with placebo (IgE, +0.59 vs +0.21 log kU/L; IgG(4), +0.18 vs +0.04 log relative units; both, P < 0.0001). At least 1 AE was reported in 58% of patients in the AIT group and in 40% of patients in the placebo group. Most AEs considered related to AIT were mild or moderate events in the mouth, throat, and/or ears (eg, oral pruritus). Four serious AEs were reported in the AIT group (sinusitis, road traffic accident, salmonellosis, meniscus lesion), but all were considered unlikely to be related to treatment. Three percent of the grass AIT group and 2% of the placebo group were withdrawn from the trial due to an AE. CONCLUSIONS: In-season initiation of grass AIT was associated with an immunomodulatory response in terms of induction of IgE-blocking factor, specific IgE, and specific IgG(4). In-season initiation of grass AIT was generally well tolerated in this group of adults with moderate to severe grass pollen-induced rhinoconjunctivitis. These findings are consistent with those related to the preseasonal initiation of AIT therapy.
机译：背景：草过敏免疫治疗片（AIT）（Ph草草花粉过敏原提取物）的产品特征摘要指出，如果开始治疗的第一个花粉季节大于等于2个月，则可以观察到临床效果（8个星期）在花粉季节开始之前。但是，由于对草过敏的患者可能会在本季节内首先出现在医生面前，因此与要求患者在下一个花粉季节之前回到家中相比，立即开始治疗（即按季节开始）可能会增加治疗依从性并降低疾病发展的风险。开始治疗。这种“季节性方法”可以为更多患者提供特异性免疫疗法的潜在有益治疗选择。然而，迄今为止，尚不清楚季节内治疗开始的免疫调节作用和耐受性。目的：本研究的目的是评估在季节内开始使用草AIT治疗的免疫学效果和耐受性。方法：该多中心，随机，双盲，安慰剂对照试验在德国和奥地利进行。招募有草花粉过敏（阳性皮肤点刺试验和特定草花粉免疫球蛋白[Ig] E）和草花粉诱导的中度至重度持续性鼻结膜炎的成年人。从2008年草粉花粉季节开始，将患者随机分配为每天接受一次草AIT或安慰剂，并持续8至10周。主要终点是IgE阻断因子（与IgE竞争过敏原结合的血清成分）相对于基线的变化。次要终点包括特定IgE和IgG（4）相对于基线的变化以及耐受性的度量（主要通过不良事件[AE]进行评估）。研究人员在基线和治疗后获得了用于免疫学评估的血样。在整个试验和随访期间，记录研究人员观察到的和/或患者报告的所有不良事件。结果：共纳入276例患者，并形成完整的分析集（平均年龄35岁;男性55％，女性45％;白人99％;平均体重76 kg;哮喘病史：41％;平均病程草过敏，15.1年）。在AIT草组（n = 219）和安慰剂组（n = 57）之间，病史无重大差异。与安慰剂相比，草AIT的IgE阻断因子平均浓度相对于基线的变化显着更大（+0.14 vs +0.05; P <0.0001）。与安慰剂相比，AIT的特异性IgE和特异性IgG（4）浓度相对于基线的变化显着更大（IgE，+ 0.59 vs +0.21 log kU / L; IgG（4），+ 0.18 vs +0.04 log相对单位;两者，P <0.0001）。据报道，AIT组中58％的患者和安慰剂组中40％的患者至少有1种AE。被认为与AIT相关的大多数AE是口腔，咽喉和/或耳朵的轻度或中度事件（例如口腔瘙痒）。在AIT组中报告了四种严重的AE（鼻窦炎，道路交通事故，沙门氏菌病，半月板病变），但认为它们均与治疗无关。由于AE，草类AIT组的3％和安慰剂组的2％退出了试验。结论：在诱导IgE阻断因子，特异性IgE和特异性IgG（4）方面，草AIT的季节启动与免疫调节反应相关。在这组中度至重度由花粉引起的鼻结膜炎的成年人中，一般可以很好地耐受季节性AIT。这些发现与季节前开始进行AIT治疗有关。

著录项

相似文献

  • 外文文献
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号